Neural Mechanisms Underlying Alcohol Induced Disinhibition

March 11, 2013 updated by: Technische Universität Dresden

Collaboration on Alcohol Self Administration in Adolescents and Young Adults - Specific Aim 2: To Examine the Effect of Acute Alcohol Administration on Forebrain Disinhibition Using Functional Magnetic Resonance Imaging (fMRI)

Forty 18-year-old social drinkers will be selected from the sample tested in specific aim 1 ("Prospective Assessment of Adolescent Drinking Trajectories With Computer-Assisted Self-administration of Ethanol (CASE)"; ClinicalTrials.gov identifier: NCT01063166). The functional magnetic resonance imaging blood-oxygen-level-dependent (fMRI BOLD) activity related to disinhibition measured with the Stop Signal task will be assessed during a continuous infusion of alcohol, clamping the arterial Breath Alcohol Concentration (aBAC) at 60 mg% for approximately one hour. It will be examined whether this fMRI BOLD activity is associated with the initial drinking trajectories and the alcohol consumption at age 18 and at age 20 identified in specific aim 1. Furthermore, fMRI will be used with the Taylor Aggression Paradigm to determine which brain areas mediate increased physical aggression during the same continuous infusion of alcohol as described above. All participants will undergo an alcohol and a placebo fMRI session.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Saxony
      • Dresden, Saxony, Germany, 01187
        • Technische Universitaet Dresden - Dresden fMRT-Neuroimaging Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 19 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Residents living within 15 km (9.5 miles) from downtown Dresden

Description

Inclusion Criteria:

  • male and female Caucasian volunteers aged 18 years/0 months to 19 years/11 months;
  • written informed consent by the subject;
  • habitual social drinking during the two months preceding participation, defined by at least one drinking day in any two weeks-interval;
  • at least one prior experience of alcohol intoxication
  • being able to abstain from tobacco use for four hours without developing nicotine withdrawal symptoms;
  • effective contraception in female participants;
  • consenting to abstain from any illegal substance use for 2 weeks prior to participation;
  • living within 15 km (9.5 miles) from downtown Dresden;
  • sufficient information concerning alcohol use in both parents and in at least four second-degree relatives

Exclusion Criteria:

  • prior medical treatment due to alcohol use;
  • current or prior history of any serious disease, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, alcohol or drug dependence, but not alcohol abuse;
  • current history of Axis-I psychiatric illness, including premenstrual dysphoric disorder;
  • current or prior history of alcohol-induced flushing reactions;
  • positive urine screen for cannabinoids, cocaine, amphetamines, opiates, or benzodiazepines;
  • light or non-drinkers: averaging less than 2 standard drinks per week in the preceding two months;
  • intention to become pregnant
  • pregnancy or positive urine pregnancy screening or breast-feeding;
  • any alcohol intake on the test day or the day before;
  • use of medications known to interact with alcohol within 2 weeks of the study;
  • positive hepatitis or HIV at screening, provided the subject consented to these tests
  • any conditions posing safety issues with the fMRI scan, such as ferromagnetic implants, cardiac pacemakers or insulin pumps

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Alcohol consumption
Time Frame: 2 years
Alcohol consumption, as measured by a Timeline Followback Interview.
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Absolute perfusion levels assessed with arterial spin labeling
Time Frame: 1 week
1 week
Behavioural Stop Signal Reaction Time (SSRT)
Time Frame: 1 week
1 week
BOLD fMRI correlate of aggression
Time Frame: 1 week
1 week
Taylor aggression score
Time Frame: 1 week
1 week
BOLD fMRI correlate of disinhibition
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Technische Universität Dresden

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Indiana University School of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael N. Smolka, Prof. Dr., Technische Universitaet Dresden - - Faculty of Medicine Carl Gustav Carus - Department of Psychiatry and Psychotherapy
  • Principal Investigator: Ulrich S. Zimmermann, Dr., Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • U01 AA017900 SA2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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